Demarcation template for hazardous contaminant testing

ABSTRACT

Aspects of the disclosure relate to demarcation templates for demarcating a test area on a test surface and for providing visual guidance to a user to precisely and accurately swab the test surface in order to determine the presence and/or concentration of an analyte of interest on the test surface. In one aspect, the analyte of interest is a hazardous contaminant. Some templates can include alignment markings around the border demarcating the test area to provide such guidance to users, and can include graphical use instructions on a removable central portion of the template. The template can be adhesive to be securely fixed to the test surface for accurate demarcation of the test area throughout sampling.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/561,557, filed on Sep. 21, 2017, entitled“DEMARCATION TEMPLATE FOR HAZARDOUS CONTAMINANT TESTING,” the contentsof which are hereby incorporated by reference herein.

TECHNICAL FIELD

Systems and methods disclosed herein are directed to environmentalcontaminant testing, and, more particularly, to templates that guideusers to accurately sample a test area.

BACKGROUND

Antineoplastic drugs are used to treat cancer, and are most often foundin a small molecule (like fluoruracil) or antibody format (likeRituximab). Detection of antineoplastic drugs is critical fordetermining if there is contamination or leakage where the drugs areused and/or dispensed, such as hospital and pharmacy areas.

The nature of antineoplastic drugs make them harmful to healthy cellsand tissues as well as the cancerous cells. Precautions should be takento eliminate or reduce occupational exposure to antineoplastic drugs forhealthcare workers. Pharmacists who prepare these drugs and nurses whomay prepare and administer them are the two occupational groups who havethe highest potential exposure to antineoplastic agents. Additionally,physicians and operating room personnel may also be exposed through thetreatment of patients, as patients treated with antineoplastic drugs canexcrete these drugs. Hospital staff, such as shipping and receivingpersonnel, custodial workers, laundry workers and waste handlers, allhave the potential to be exposed to these drugs during the course oftheir work. The increased use of antineoplastic agents in veterinaryoncology also puts these workers at risk for exposure to these drugs.

SUMMARY

Antineoplastic drugs are antiproliferative. In some cases they affectthe process of cell division by damaging DNA and initiating apoptosis, aform of programmed cell death. While this can be desirable forpreventing development and spread of neoplastic (e.g., cancerous) cells,antineoplastic drugs can also affect rapidly dividing non-cancerouscells. As such, antineoplastic drugs can suppress healthy biologicalfunctions including bone marrow growth, healing, hair growth, andfertility, to name a few examples.

Studies have associated workplace exposures to antineoplastic drugs withhealth effects such as skin rashes, hair loss, infertility (temporaryand permanent), effects on reproduction and the developing fetus inpregnant women, increased genotoxic effects (e.g., destructive effectson genetic material that can cause mutations), hearing impairment andcancer. These health risks are influenced by the extent of the exposureand the potency and toxicity of the hazardous drug. Although thepotential therapeutic benefits of hazardous drugs may outweigh the risksof such side effects for ill patients, exposed health care workers riskthese same side effects with no therapeutic benefit. Further, it isknown that exposures to even very small concentrations of antineoplasticdrugs may be hazardous for workers who handle them or work near them,and for known carcinogenic agents there is no safe level of exposure.

Environmental sampling can be used to determine the level of workplacecontamination by antineoplastic agents. Sampling and decontamination ofcontaminated areas is complicated, however, by a lack of quick,inexpensive methods to first identify these areas and then determine thelevel of success of the decontamination. Although analytical methods areavailable for testing for the presence of antineoplastic drugs inenvironmental samples, these methods require shipment to outside labs,delaying the receipt of sampling results.

In one example sampling system suitable for use with the devices of thepresent disclosure, work surfaces can be tested for the presence ofantineoplastic agents in an environment. Results of the test can beprovided very quickly, at the site of testing, so that the operator ofthe test, other personnel in the area, and/or remote systems can bealerted to the presence and/or concentration of antineoplastic agentsvery close in time to the test event, in some cases within 1-2 minutes.Methods of testing include providing the surface with a buffer solutionand wiping the wetted surface with an absorbent swab, or by wiping thesurface with a swab pre-wetted with the buffer solution. The bufferfluid can have properties that assist in picking up contaminants fromthe surface. In some implementations, the buffer fluid can haveproperties that assist in releasing collected contaminants from swabmaterial. The collected contaminants can be mixed into a homogeneoussolution for testing. The buffer solution, together with any collectedcontaminants, can be expressed or extracted from the swab to form aliquid sample. This liquid sample can be analyzed for presence and/orquantity of specific antineoplastic agents. For example, the solutioncan be provided onto an assay (such as but not limited to a lateral flowassay) which is read by an assay reader device to identify presenceand/or a concentration of the contaminant in the liquid sample.

The accuracy of testing for the presence and/or concentration of acontaminant in a fluid sample is highly dependent on various testfactors. Test results can provide a measurement in the form ofconcentration of contaminant in a tested environment, for examplecontaminant mass per square unit area. Accordingly, precision andaccuracy in measuring the sampled area can be an important factor toobtain an accurate test result. Accurately measuring a specific samplearea can involve demarcating a test area of the surface to be tested andthen sampling the entire demarked area. Existing sampling systemsrequire the test operator to measure out test area dimensions and placephysical markers, such as adhesive dots, to define a rectangular testarea. The test operator of such existing systems is then responsible forensuring that the entire area is swabbed before cleaning up the markers.This approach has a number of drawbacks including requiring a lengthysetup, being subject to measurement and marker placement errors, andincreasing the risk of exposure of the test operator to potentialhazardous drug contamination through placement and removal of themarkers.

These and other problems are addressed in embodiments of the hazardousdrug collection and detection systems described herein, which includetemplates having a removable instructions portion with graphicalsampling instructions, and a border forming an open area configured todemarcate a test area with the removable instructions portion removed.The template can also include an adhesive layer for securing it to atest surface. The present technology provides improved accuracy foridentifying antineoplastic drug concentrations, including trace amountsof antineoplastic drugs, compared to existing systems. The disclosedtemplates can enable more accurate sampling from the tested area, forexample by the consistent demarcation of a pre-specified area. Adetection system is capable of accurately detecting quantities of eventrace amounts of antineoplastic agents based on the known sampled areaand of providing results quickly (including immediately aftercollection). Advantageously, testing and detection can occur at thelocation of the collection so that immediate, quantitative assessment ofcontamination level can be determined without the delay required forlaboratory sample processing.

Accordingly, one aspect relates to a system for guiding collection of ahazardous contaminant sample, comprising a handle configured forcollection of the hazardous contaminant sample from a test surface; anda template including a border having an outer perimeter and an innerperimeter with edges of the inner perimeter defining an open areaconfigured to demarcate a test area for the collection of the hazardouscontaminant sample, and a plurality of alignment markings provided alongat least one of the edges of the inner perimeter, the plurality ofalignment markings provided at a spacing selected to provide visualguidance to a user for wiping the entire test area with the handle.

In some embodiments of the system, the border is formed from asubstrate, wherein the plurality of alignment markings are printed on afirst surface of the substrate, the template further comprising anadhesive provided on a second surface of the substrate opposing thefirst surface. Some further embodiments comprise a protective backinglayer removably provided to cover the adhesive prior to use. Somefurther embodiments comprise a removable portion of the template securedto the protective backing layer within the open area of the border. Insome further embodiments, the substrate comprises the removable portion,the removable portion further comprising at least one graphicalinstruction for guiding the user through the collection of the hazardouscontaminant sample printed on the first surface. In some furtherembodiments, the substrate comprises the removable portion, the systemfurther comprising a separation line extending through the substrate andseparating the border and the removable portion.

Some embodiments of the system further comprise a reader deviceconfigured to determine a test result based on the hazardous contaminantsample collected from the test surface within the test area demarcatedby the template. In some further embodiments, the border comprises amachine-readable pattern identifying the surface area of the test area,wherein the reader device includes a scanning device, at least onecomputer-readable memory having stored thereon executable instructions,and one or more processors in communication with the at least onecomputer-readable memory and configured to execute the instructions tocause the reader device to cause the scanning device to capture datarepresenting the machine-readable pattern, and determine the surfacearea of the test area based on analyzing the data.

Another aspect relates to a system for guiding collection of a hazardouscontaminant sample, comprising a template including a border having anouter perimeter and an inner perimeter with edges of the inner perimeterdefining an open area configured to demarcate a test area for thecollection of the hazardous contaminant sample; and a reader deviceconfigured to receive an indication of a surface area of the test areaof the template, and to determine a test result based on the hazardouscontaminant sample from the test surface and on the surface area of thetest area of the template.

In some embodiments of the system, the border comprises a plurality ofalignment markings provided along at least one of the edges of the innerperimeter, the plurality of alignment markings provided at a spacingselected to provide visual guidance to a user for wiping the entire testarea. In some further embodiments, the border is formed from asubstrate, and wherein the plurality of alignment markings are printedon a first surface of the substrate, the template further comprising anadhesive provided on a second surface of the substrate opposing thefirst surface. Some further embodiments comprise a protective backinglayer removably provided to cover the adhesive prior to use. Somefurther embodiments comprise a removable portion of the template securedto the protective backing layer within the open area of the border. Insome further embodiments, the substrate comprises the removable portion,the removable portion further comprising at least one graphicalinstruction for guiding the user through the collection of the hazardouscontaminant sample printed on the first surface. In some furtherembodiments, the substrate comprises the removable portion, the systemfurther comprising a separation line extending through the substrate andseparating the border and the removable portion.

In some embodiments of the system, one surface of the template isprovided with an adhesive, the template further comprising a protectivebacking layer removably provided to cover the adhesive prior to use.

Another aspect relates to a template for guiding collection of ahazardous contaminant sample from a surface, comprising a substratecomprising a border having an outer perimeter and an inner perimeterwith edges of the inner perimeter defining an open area configured todemarcate a test area on the surface for the collection of the hazardouscontaminant sample, a separation line provided as one or more cutsthrough the substrate along the inner perimeter, and a removable portionprovided within the inner perimeter; an adhesive provided on a surfaceof the substrate configured to secure at least the border to thesurface; and a protective backing layer removably provided to cover theadhesive prior to use.

In some embodiments of the template, the adhesive secures the border andthe removable portion to the protective backing layer prior to use. Insome embodiments of the template, the border comprises a plurality ofalignment markings provided at a spacing selected to provide visualguidance to a user for wiping the entire test area. In some embodimentsof the template, the removable portion comprises at least one graphicalinstruction for guiding a user through the collection of the hazardouscontaminant sample. In some embodiments of the template, the removableportion is configured to be removed from the border prior to thecollection of the hazardous contaminant sample.

Another aspect relates to a method for applying a template for guidingcollection of a hazardous contaminant sample to a surface, comprisingobtaining a template as described herein; peeling the border away fromthe protective backing layer at a first corner of the border; securingthe first corner of the border to the surface using an exposed portionof the adhesive; folding the protective backing layer away from thefirst corner and under a portion of the border that is unsecured to thesurface; peeling the protective backing layer away from the first cornerto progressively expose more of the adhesive; securing additionalportions of the border to the surface using corresponding portions ofthe adhesive as it is progressively exposed; and upon fully removing theprotective backing layer from the border, securing a second corner ofthe border to the surface, the second corner diagonally opposing thefirst corner.

Another aspect relates to a method for applying a template for guidingcollection of a hazardous contaminant sample to a surface, comprisingobtaining a template as described herein; completely removing the borderfrom the protective backing layer; securing a first edge of the borderto the surface using a portion of the adhesive provided on the firstedge; progressively securing portions of second and third edges of theborder onto the surface using corresponding portions of the adhesiveprovided on the portions of the second and third edges, the second andthird edges extending from the first edge; and securing a fourth edge ofthe border to the surface using a portion of the adhesive provided onthe fourth edge, the fourth edge opposing the first edge and connectingthe second and third edges.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed aspects will hereinafter be described in conjunction withthe appended drawings, provided to illustrate and not to limit thedisclosed aspects, wherein like designations denote like elements.

FIGS. 1A-1D graphically illustrate steps of an example method ofcollecting and testing a liquid sample as described herein.

FIGS. 2A-2C illustrate an example template as described herein.

FIG. 3A illustrates an example handle that can be used to sample a testarea demarcated by embodiments of the disclosed templates.

FIG. 3B illustrates an example swabbing pattern using the handle of FIG.3A with the template of FIG. 2B.

FIG. 3C illustrates another example swabbing pattern using the handle ofFIG. 3A with the template of FIG. 2B.

FIG. 4 illustrates example techniques for application of the template ofFIGS. 2A-2C to a test surface.

FIGS. 5A and 5B depict photographs of the template of FIGS. 2A-2C atdifferent stages of the application process of FIG. 4.

DETAILED DESCRIPTION

Embodiments of the disclosure relate to systems and techniques fordetection of hazardous environmental contaminants, such as but notlimited to antineoplastic drugs used in the treatment of cancer, withincreased sensitivity to trace concentrations of antineoplastic drugs incollected samples. A kit for such testing can include a collectionsystem and a testing device, and the collection system can include atemplate for demarcating the test area. The template can have anadhesive backing, a border defining an open area for demarcating thetest area, and a portion that is separable from the border to create theopen area providing use instructions to a user. The border can includemarkings that assist a user in performing sampling in a regular,precise, constrained way that thoroughly contacts all or substantiallyall of the test surface exposed within the open area of the template.Throughout this disclosure, example systems, kits, and methods will bedescribed with reference to collection, testing, and detection ofantineoplastic agents, but it will be understood that the presenttechnology can be used to collect, test, and detect any particle,molecule, or analyte of interest.

A precise method of demarcating and sampling from a specified area canbe important in order to obtain an accurate test result in the form ofdrug mass per square unit area (e.g., nanograms per square centimeter).For example, a sample can be collected from a test surface by using abuffer liquid to wet the surface and using a swab to absorb the bufferliquid and any particles of hazardous drug contamination. Alternatively,any particles of hazardous drug contamination can be collected by wipingthe surface with a swab pre-wetted with the buffer solution. When thesample is tested, a test device may be able to identify theconcentration of the hazardous drug in the volume of the liquid sample.In order to convert this measurement into a measurement of drugconcentration on the test surface, some implementations can use thefollowing formula:

α=(C _(vb))/(Aη _(p)η_(e))

where a represents the contamination surface density (e.g., ng/cm²), Crepresents the concentration of the sample in the liquid sample, v_(b)represents the fluid volume of the buffer solution used to collect thesample, A represents the surface area swabbed, η_(p) represents thepick-up efficiency of the swab material and buffer solution, and η_(e)represents the extraction efficiency of contaminant picked up by theswab material. The goal is to have a high concentration signal with lowvariability, however noise (e.g., variation) in these variables cancause the test to generate either false positive or false negativeresults. The disclosed templates provide guidance for reducing thevariation in the surface area swabbed, leading to heightened accuracy insample testing, and in particular to a more accurate contaminationsurface density measurement.

Embodiments of the systems and methods described herein canadvantageously determine two important aspects regarding contaminationof a tested surface quickly and with high precision. First, thedisclosed systems and methods can determine the presence of even a verysmall amount of a hazardous contaminant. This provides an importantbenefit over manual sampling (e.g., sampling performed without thedisclosed templates), because if there are just a few molecules on thesurface, the user may miss the molecules entirely if they do not samplethe test area in a regular, constrained, precise way. This type ofsampling can lead to a false negative, leading to a missed opportunityto fix a leak or breach of protocol. In one example, the false negativereading may lead to healthcare workers continuing work in the testedarea, resulting in their exposure to the hazardous contaminant. Thedisclosed templates can aid users in reliably sampling specificdemarcated areas. Embodiments of the physical templates described hereincan ensure the user is reliably informed of the presence of even smallamounts of hazardous agent, for example by guiding the user to perform athorough sampling such that the results provided by test devices aremore accurate than results based on other sampling methods.

Second, the disclosed systems and methods can be used to more preciselydetermine the concentration of a detected hazardous contaminant byproviding an accurate metric regarding actual sampled area. This isimportant because the presence of a very small or trace concentrationsof certain hazardous drugs may be tolerable or even expected within anenvironment in some scenarios, but the difference between a smaller,acceptable trace concentration and a larger, unacceptable andpotentially dangerous trace concentration may be very small (e.g., onthe order of nanograms per centimeter squared). The disclosed templates,together with test systems and methods described herein, enable the userto now know very quickly and reliably if the concentration of ahazardous contaminant has elevated to dangerous conditions.

Although the templates, test systems, and methods described herein aretypically described herein with reference to test strips and lateralflow assay reader devices, it will be appreciated that the describedtemplates can be implemented in any detection system that seeks todetect the presence of and/or quantify any particle, molecule, oranalyte of interest. The test devices described herein are not limitedto lateral flow assay test strips, nor to test strips generally. Anysuitable test device can be used with implementations of the templatesdescribed herein. Features described herein can be implemented in readerdevices that analyze other types of assays, such as but not limited tomolecular assays, and provide a test result. Further, the collectedfluid can be transferred to a centrifuge, spectrometer, chemical assay,or other suitable test device to determine the presence and/orconcentration of the target particle, molecule, or analyte of interest,including but not limited to hazardous substances. Additionally,although templates described herein are described as being applied tohorizontal and vertical surfaces in some non-limiting examples, thetemplates are not limited to application to planar surfaces. Templatesdescribed herein can be used to test, for example, non-planar surfacessuch as but not limited to IV poles, curved desk or door handles, andother fixtures that are commonly present in the test environment andthat may be contaminated with even a minute amount of a hazardous substance.

Drugs successfully treat many types of illnesses and injuries, butvirtually all drugs have side effects associated with their use. Not alladverse side effects classify as hazardous, however. In the presentdisclosure, the term “hazardous drugs” is used according to the meaningadopted by the American Society of Health-System Pharmacists (ASHP),which refers to a drug as hazardous if studies in animals or humans haveindicated that exposures to them have any one of four characteristics:genotoxicity; carcinogenicity; teratogenicity or fertility impairment;and serious organ damage or other toxic manifestation at low doses inexperimental animals or treated patients.

Although described in the example context of ascertaining the presenceand/or concentration of hazardous drugs such as antineoplastic agents,it will be appreciated that the disclosed devices and techniques fordemarcating a test sampling area and guiding user sampling procedurescan be used to detect the presence and/or concentration of any analyteof interest. An analyte can include, for example, drugs (both hazardousand non-hazardous), antibodies, proteins, haptens, nucleic acids andamplicons.

Various embodiments will be described below in conjunction with thedrawings for purposes of illustration. It should be appreciated thatmany other implementations of the disclosed concepts are possible, andvarious advantages can be achieved with the disclosed implementations.

Overview of Example Sampling Method

FIGS. 1A-1D graphically illustrate steps of an example method ofcollecting and testing a liquid sample that can be performed using atemplate as described herein. FIG. 1A illustrates example steps of atesting method 100A for testing for the presence of an analyte on a testsurface. One, some, or all of the depicted blocks of FIG. 1A can beprinted as graphical user interface instructions on a template (eitherthe border or the portion separable from the border to create the openarea for sampling), the packaging of an assay and/or collection kit, orcan be presented on a display screen of an assay reader device, a testarea terminal, or a personal computing device of the user.

At block 101, the user can identify a sample location and gather acollection kit, assay cartridges, and a template. The collection kit caninclude a swab attached to a handle and a collection container. In someexamples, the swab is pre-wetted with buffer solution and packagedtogether with the handle in a first sealed pouch and the collectioncontainer is packaged in a second sealed pouch. The assay cartridge mayinclude an assay device housed inside a cartridge having a window orport aligned with a sample receiving zone of the assay device. In oneimplementation, the assay device is a test strip, for example but notlimited to a lateral flow assay test strip. Also at block 101 the usercan put on clean gloves prior to each sample collection and/or openingof the collection kit, both to protect the user from potentialcontamination on the surface and to protect the collected sample fromcontamination with anything on the user's hands.

At block 102, the user can establish a test area on the test surface.For example, the user can place a template over the intended location toclearly demarcate the area that will be swabbed. As described herein,block 102 can involve a user removing a central portion of the templateto create an open area within a border, peeling the border away from anadhesive backing, and carefully placing the adhesive border on the testsurface to ensure that the edges demarcating the open area arepositioned straight and flat on the test surface. Also at block 102 theuser can open the collection kit packaging, including opening theseparately-packaged swab and handle.

At block 103, the user can swab the test area using slow and firmstrokes. As shown, the user can methodically pass the swab in straightlines along the height of the test area all the way across the width ofthe test area. The template border can include markings that assist theuser in maintaining even separation between adjacent swab stroke linesacross the test surface. Such markings may be spaced apart by a distancedetermined based on a known width of a swab handle provided with thetemplate, such that maintaining alignment of the swab handle with themarkings causes the entire test area to be sampled. In some embodiments,the swab handle can additionally have markings, for example at thecenter point along its width, to further assist the sampling user withmaintaining alignment between the swab handle and the template markings.

The test area may be one square foot in some embodiments, for exampledemarcated as a 12 inches by 12 inches (144 square inches) region. Otherexamples can use greater or smaller areas for collection including 10inches by 10 inches, 8 inches by 8 inches, 6 inches by 6 inches and 4inches by 4 inches, non-square rectangular regions (e.g., a 9 inches by16 inches rectangle), and non-rectangular regions (e.g. circles).Different-sized templates may be specified for usage with different testsurfaces. The particular template used can be indicated to a readerdevice, for example via a manual user input or via a barcode or otheridentifying pattern on the template scanned by the reader device. Forexample, a template providing a swab area of a 12 inches by 12 inchesregion can be indicated for use in sampling a countertop, while asmaller template demarcating a smaller swab area can be indicated forswabbing an IV pole. The reader device can adjust its test resultcalculations to account for the actual area tested, as indicated by theparticular template used for the sampling procedure.

At block 104, the user can insert the swab into the collectioncontainer. In some examples, the collection container includes at-shaped well. Though not illustrated, the swab may have a t-shapedcross-section that substantially matches that of the container well. Theuser seals the container with a top that includes a dripper cap, andfully inverts (e.g., turn upside down and then return to right-side-up)the sealed container five times. During these inversions, the liquid inthe well of the container washes primarily over the swab material due tothe cross-sectional shape of the well, and the handle slides within thewell due to the well having a greater height than the handle. Theinversion combined with the geometries of the container and handle andthe flow of the buffer solution can extract collected contaminants fromthe swab material.

At block 106, the user can leave the swab and handle inside thecontainer, remove the dripper cap, and squeeze (or allow gravity todraw) four drops into the sample well on each assay cartridge. Forexample, in some embodiments the user may drop sample onto multipleassays each designed to test for a different drug. In some examplesanywhere between three and ten drops can produce suitable results on theassay. A drop is an approximated unit of measure of volume correspondingto the amount of liquid dispensed as one drop from a dropper or dripchamber via gravitational pull (sometimes aided by a positive pressurecreated within the container holding the liquid). Though the precisevolume of any given drop depends upon factors such as the surfacetension of the liquid of the drop, the strength of the gravitationalfield pulling on the drop, and the device and technique used to producethe drop, it is commonly considered to be a volume of 0.05 mL. Inalternate embodiments the user may mechanically couple a fluid transferportion of the collection device to a fluid transfer portion of theassay device to release a controlled volume of sample through a closedfluid pathway.

At block 107, the user can use a timer to allow the sample to developfor a period of time. For example, the sample can develop for about oneminute, about two minutes, about three minutes, about four minutes,about five minutes, about six minutes, or some other amount of time.Other development times are possible. In some embodiments the timer canbe built in to the programming of the reader device that reads theassay. The development time can vary depending on the particular testthat is being performed and the particular operating parameters of theassay device.

At block 108, the user can insert the assay cartridge into an assayreader device. The assay cartridge can be inserted into the ready deviceprior to or after the sample is developed, depending upon theoperational mode of the device. In some embodiments, the user maysequentially insert multiple cartridges for testing different aspects ofthe sample or for ensuring repeatability of test results.

At block 109, the assay reader device reads portions of the insertedcartridge (including, for example, detecting optical signals fromexposed areas of a capture zone of a test strip housed in thecartridge), analyzes the signals to determine optical changes to testzone location(s) and optionally control zone location(s), determines aresult based on the optical changes, and displays the result to theuser. The device can optionally store the result or transmit the resultover a network to a centralized data repository. As illustrated, thedevice displays a negative result for the presence of Doxorubicin in thesample. In other embodiments the device can display a specific detectedconcentration level in the sample and/or determined for the test area,and optionally can display confidence values in the determined result.

Embodiments of the reader devices described herein can determine thepresence or the absence of a hazardous drug on a tested surface with ahigh degree of confidence, and display an indication of this test resultto a user very quickly (in some instances, within 1 to 2 minutes) afterthe user tests the surface. In some cases, the reader device candetermine a concentration of contamination and display an indication ofthe determined concentration to the user very quickly (in someinstances, within 1 to 2 minutes) after the user tests the surface. Instill further examples, the reader device correlates a detected level ofcontamination with a risk of human uptake and/or risk of harmfulexposure to humans. To illustrate in one non-limiting example, anunintended human uptake of 1.0 ng/cm² of Cyclophosphamide, a hazardousantineoplastic drug, can be deemed a harmful exposure and/or exposure toa carcinogen. It will be understood that a different level ofcontamination of Cyclophosphamide could be established as a thresholdfor harmful exposure, and that the level of contamination for variousantineoplastic drugs can be set to different levels depending on theneeds of the user and the testing environment.

In this example, the reader device is configured to detect a level ofcontamination of Cyclophosphamide for a 12 inch by 12 inch (just as anexample) sampled area that is 1/10^(th) of this 1.0 ng/cm² thresholdlevel of Cyclophosphamide contamination, or 0.1 ng/cm². For example, thedynamic range of the assay test device (and reader devices describedherein that read the disclosed assay devices) can be capable ofdetecting a level of contamination of Cyclophosphamide as low as about0.1 ng/cm² per 12 inch by 12 inch sample test area. In one non-limitingembodiment, the reader device is configured to display an indication ofan actual measured concentration of Cyclophosphamide. For example, adisplay on the reader device may display the reading “0.085 ng/cm²” tothe user upon completion of reading the test device. In anothernon-limiting embodiment, the reader device is configured to indicate abinary result to the user based on an actual measured concentration ofCyclophosphamide. For example, a display on the reader device maydisplay the reading “−” or “−Cyclophosphamide” to the user uponcompletion of reading the test device when the actual measuredconcentration of Cyclophosphamide is less than about 0.1 ng/cm²(equivalent to a 93 ng mass of Cyclophosphamide for a 12 inch by 12 inchtest sample area). The display on the reader device may display thereading “+” or “+Cyclophosphamide” to the user upon completion ofreading the test device when the actual measured concentration ofCyclophosphamide is about 0.1 ng/cm² or greater (equivalent to a 93 ngmass of Cyclophosphamide for a 12 inch by 12 inch test sample area).

In some examples, the reader device is configured to correlate an actualmeasurement of contamination with a risk of human uptake and/or risk ofharmful exposure to humans and to display an indication of the risk tothe user upon completion of reading the test device. For instance, thereader device may be configured to correlate an actual measuredconcentration of Cyclophosphamide of less than about 0.1 ng/cm² as areading within a window of acceptable error and/or with a low risk ofharmful exposure. In this case, the reader device can display a readingof “No further action” to the user. The reader device can be configuredto correlate an actual measured concentration of Cyclophosphamide ofabout 0.1 ng/cm² (equivalent to a 93 ng mass of Cyclophosphamide for a12 inch by 12 inch test sample area) with a moderate risk of harmfulexposure. In this case, the reader device can display a reading of“Notify others; Begin Decontamination” to the user. The reader devicecan be configured to correlate an actual measured concentration ofCyclophosphamide of greater than about 0.1 ng/cm² (equivalent to a 93 ngmass of Cyclophosphamide for a 12 inch by 12 inch test sample area) as areading within a window of unacceptably high contamination. In thiscase, the reader device can display a reading of “Evacuate immediately”to the user. The reader device may also automatically transmit a warningor alert to the user with a warning sound or light (for example, a voiceprompt or bright flashing light); transmit a warning or alert to otherpersonnel within a distance of the reader device and the tested surface(for example, initiate voice prompts to evacuate the immediate area,emit a high-decibel siren, etc.); and/or transmit a warning or alert topersonnel within or outside the physical location where the test eventoccurred (transmit, via a wired or wireless connection, an emergencynotification to a head pharmacist, nurse, manager, safety officer, orregulatory agency that includes location of the test event, hazardousdrug name, and the measured concentration of the hazardous drug). Theseexamples are not intended to be limiting and it will be understood thatother concentrations, thresholds, display readings, and warnings can beimplemented in the systems described herein.

After testing the user can re-seal the container with a dripper cap anddispose of the collection device and assay (for example in compliancewith hazardous waste regulations). Optionally, the user can execute anyneeded decontamination procedures, re-test a decontaminated surface, andperform required reporting of the result.

FIG. 1B illustrates another testing method 100B that depicts details ofsteps 103, 104, and 106 of the process 100A using an alternateembodiment of the collection device.

The method 100B begins at step 105, in which a user can remove a handle140 from a container 130 containing a predetermined volume of bufferfluid 135. The handle 140 has a swab 245 secured to one end that ispre-wetted with the buffer fluid 135. In other implementations, the usercan separately apply a fluid that did not originate from the container130 to the test surface. For example, the buffer fluid 135 can beprovided separately, applied to the test surface, and absorbed using theswab 145. The buffer fluid 135 helps lift contaminants from the testsurface into the swab.

At step 110, optionally in some embodiments the swab head can rotate toassist in making and maintaining contact between the swab 145 and thetest surface 150.

At step 115, the user can swab a designated test area of the testsurface 150. It can be preferable in some implementations to swab theentirety of the test area and only within the test area so as togenerate an accurate measurement of the concentration of thecontaminant, particularly for contaminants where even small quantitiesper area are harmful to users. The disclosed templates can be used toassist with demarcating and manually tracking the swabbed area. Swabbingthe entirety of the test area and only within the test area can alsoallow a reader device as described herein to generate an accuratemeasurement of the concentration of the contaminant per unit area insituations where a very small amount of contaminant is present. Even ifthe amount of contaminant detected is very small and not immediatelyharmful to persons in the immediate area, detection of contaminant inany amount can alert the user to a leak or unintended release ofhazardous material. Further, for some hazardous drugs there is no safeexposure level. As such, some embodiments of step 115 can involveadhering a template to the test surface to provide an area demarcationover the test area to assist the user with swabbing only a predeterminedarea, and can further involve using markings on the template border tomanually constrain and affirmatively guide the user's actions toincrease the likelihood that the entire demarcated area is swabbed in amanner that optimizes the test result, including detection andquantification of a contaminant present in the demarcated area.

At step 120, the user can replace the swab 145 and handle 140 into thecollection container 135. Optionally, the user and/or structure of thecontainer can agitate the swab to release collected contaminants intothe fluid within the container 135.

At step 125, the user can transfer fluid to a test device, such as butnot limited to a cartridge 155 containing a lateral flow assay includinga test strip. For example, the user can drip fluid from the container130 onto a sample receiving zone of the test strip. In some embodiments,the cartridge 155 (or other test system) and container 130 can bestructured to mechanically mate via a fluid-tight connection so as toprevent accidental exposure of potentially contaminated fluid to usersand/or the testing environment.

FIG. 1C illustrates a further step of inserting the cartridge 155 intoan aperture 170 of reader device 160. Although the following example isdescribed with reference to reader device 300, an assay test device(whether housed within cartridge 320 or not housed within a cartridge)can be read by any suitable reader as described above. Further, thoughnot illustrated, further steps can include operating the reader device160 to detect a result of the test (for example, by imaging the teststrip or detecting an optical change that occurred on the test strip),analyze the test result, and display results of the test. FIG. 1Dillustrates the reader device 160 displaying a test result on display180. In this case, the test result indicates a concentration of theanalyte of interest of 3 ng/ml.

The device 160 can be an assay reader device having an aperture 170 forreceiving an assay test strip and cartridge 155 and positioning the teststrip so that the detection zones are positioned in the optical path ofdetection components located inside the device 160. In some cases, thedetection components can include imaging components that image portionsof the assay test strip and cartridge 320 to detect optical changes inthe assay test strip. The device can also use these or additionalimaging components to scan a bar code on the cartridge, for example toidentify which detection techniques and analysis to perform.

Some embodiments of the device 160 can be configured to perform aninitial scan using a barcode scanner to scan one or more bar codes, forexample provided on templates (or barcode keys separate from thetemplates but provided with the templates), on cartridges inserted intothe aperture 170, or on separate identifiers. A barcode can identify thetype of test to be performed, the template used for sampling, the personconducting the test, the location of the test, and/or the location inthe facility of the test surface (for example pharmacy, nursing area,cabinet #, bed #, chair #, pump #, etc.). After reading any barcodeidentifiers the cartridge 155 is then inserted into the reader as shownin FIG. 1C. Barcodes are provided as an illustrative example, and invarious embodiments other identification patterns can be provided forreading by the device 160, for example serial numbers, graphicalidentifiers, radio frequency ID transmitters, and the like.

The device 160 can include a button 175 that readies the device for useand provides an input mechanism for a user to operate the device. Insome embodiments device operation mode can be set via a number orpattern of clicks of the single button 175 of the device 160. Forexample, in some implementations a single press of the button 175 canpower on the device 160 and set the device 160 to a default operationmode, and the device 160 can implement the default operation mode uponinsertion of a cartridge. A double click of the button 175 can initiatean alternate operation mode that is different than the default operationmode. Other numbers or patterns of pressing the single button 175 by auser can provide instructions to the processor of the device regarding adesired operation mode. Embodiments of a device 160 are described hereinwith reference to a single button, but other features allowing a user toselect and switch between device operation modes are possible (such asbut not limited to a single switch, knob, lever, or handle).

One example of a device operation mode is end-point read mode. In theend-point read mode, the user prepares and incubates the assay outsideof the device 160 and tracks the development time of the assay. Forexample, an assay for determining Methotrexate or Doxorubicinconcentration can have a development time of 5 minutes, so the userwould apply the fluid to the assay from a collection device as describedherein and wait for 5 minutes. At the end of the 5 minutes the userwould insert the assay 155 into the device 160 to obtain a test result.Accordingly, when operating in end-point read mode the device 160 canprovide instructions, for example audibly or on a visual display, thatinstruct a user to wait for a predetermined time after applying a sampleto an assay before inserting the assay in the device 160. In otherembodiments, when operating in end-point read mode, the device 160 maynot display any instructions but may simply read an assay upon insertioninto the device 160. Upon insertion of the assay into the base device160, an optical reader of the device can collect data (for example,image data) representing the assay for analysis in determining a resultof the assay. In some embodiments end-point read mode can be the defaultoperation mode of the device 160.

Another example of a device operation mode is walkaway mode. Whenoperating in walkaway mode, the device 160 can provide instructions forthe user to insert the assay immediately after application of thesample. In the walkaway mode according to one embodiment, the user canapply the specimen to the assay and immediately insert the assay intothe device 160. The assay will develop inside the device 160 and thedevice 160 can keep track of the time elapsed since insertion of theassay 155. At the end of the predetermined development time, the device160 can collect data representing optical changes in the assay, analyzethe data to determine a test result, and report the test result to theuser. The assay development time can be unique to each test. In someembodiments walkaway mode can be set by double-clicking the singlebutton 175 of the device 160. Further input can indicate the assaydevelopment time to the reader device. For example, a barcode scanned bya barcode reader, or a barcode provided on the assay or on a cartridgeused to hold the assay, can indicate to the device 160 a type of assaythat is inserted and a development time for that assay. Based upon thetype of assay, the device 160 can wait for the predetermined amount oftime after sample application and insertion before collecting datarepresenting optical changes in the assay.

There are many advantages associated with the ability of a user toselect and switch between device operation modes in implementations ofassay analyzers described herein. The endpoint read mode can beconvenient in large laboratories or medical practice facilities wherepersonnel typically batch process a number of tests. The walkaway modecan be useful when a single test is being performed, or when the enduser does not want to have to track the assay development time (or isnot knowledgeable or not trained on how to track the assay developmenttime accurately). The walkaway mode can advantageously reduce oreliminate the occurrence of incorrect test results due to an assay beinginserted and read (for example, imaged) too quickly (too soon before thedevelopment time of the assay has elapsed) or too slowly (too long afterthe development time of the assay has elapsed). Further, in walkawaymode the assay reader can operate to inspect the assay (for example,capture multiple images of the assay) at predetermined time intervals,for example when a kinetic graph of the assay readings is desired.

One embodiment of the disclosed device 160 includes only a single button175 on its exterior housing, such as a single power button that powersthe device 160 off and on. Embodiments of the disclosed device 160 alsoimplement two different device operation modes (although more than twodevice operation modes are possible). In order to enable the end user toselect and switch between the two device operation modes, the device 160can include instructions to implement a double-click function on thepower button. After receiving input of a single press of the button topower on the device, insertion of an assay cartridge can automaticallytrigger end-point read mode. When the processor of the device receivesinput from a user double clicking the power button, this can initiatethe stored instructions to implement the walkaway mode. This doubleclick functionality offers a simple and intuitive way for the end userto switch between different operation modes of the base assay analyzer.The double click functionality also enables the user to configure thedevice in real time to operate in the walkaway mode without requiringany additional configuration steps or additional programming of thedevice 160 by the user. It will be appreciated that the device 160 canbe provided with instructions to recognize other click modes instead ofor in addition to the double click to trigger secondary (non-default)device operation modes, for example to recognize a user pressing thebutton any predetermined number of times, pressing the button in apredetermined pattern, and/or pressing and holding the button for apredetermined length of time.

As described above, the device 160 can also include a display 180 fordisplaying instructions and/or test results to the user. After insertionof the test strip, the device 160 can read a bar code on the assay teststrip to identify the name, permissible concentration ranges of thedrug, and/or maximum permissible concentration of the drug. The device160 can inspect the inserted test strip (in one example, by “imaging”the strip or otherwise emitting light towards the test strip and thendetecting the intensity of a signal representing detected lightreflected from the test strip), and analyze the signals representing theinspected test strip to calculate results, display the results to theuser, and optionally transmit and/or locally store the results. Theresults can be calculated and displayed as contamination with anindication of positive or negative (for example, +/−; yes/no; etc.),and/or the actual amount of contamination (analyte of interest) per area(for example, Drug Concentration=0.1 ng/cm²) and/or an actual an actualcontamination (analyte of interest) per area (for example, DrugConcentration=0.1 ng/cm²), and/or an actual amount of contamination(analyte of interest) per volume of buffer solution (for example, DrugConcentration=3 ng/ml). These indications are non-limiting examples asother indications and measurement units are also suitable.

Some embodiments of the device 160 may simply display the result(s) tothe user. Some embodiments of the device 160 may also store theresult(s) in an internal memory that can be recalled, for example, byUSB connection, network connection (wired or wireless), cell phoneconnection, near field communication, Bluetooth connection, and thelike. The result(s) can also automatically be logged into the facilityrecords and tracking system of the environment (for example, facility)where the test is performed. The device 160 can also be programmed toautomatically alert any additional personnel as required, withoutfurther input or instruction by the user. For example, if the device 160reads contamination levels that are above the threshold of human uptakeand considered hazardous to for human contact, a head pharmacist, nurse,manager, or safety officer can be automatically notified with theresults and concentration of contamination to facilitate a rapidresponse. The notification can include location information, such as butnot limited to a geographic position (latitude/longitude) or descriptionof location (Hospital A, Patient Room B, etc.). That response mayinclude a detailed decontamination routine by trained personnel or usinga decontamination kit provided together or separately from the hazardouscontamination detection kit.

In some embodiments, device 160 can be a special-purpose assay readerdevice configured with computer-executable instructions for identifyingtrace concentrations of contaminants in the samples applied to teststrips. In other embodiments other suitable liquid sample test systemscan be used to identify the presence and/or concentration of a hazardousdrug.

Overview of Example Devices and Techniques for Test Area Sampling

As described above, thoroughly and accurately collecting a sample from aknown area can be beneficial or required in order to accuratelydetermine the presence or concentration of trace quantities of hazardousdrugs in a test sample. Existing sampling systems require the testoperator to measure out test area dimensions and place four adhesivedots on the test surface at the corners of a rectangular test area. Thisapproach has a number of drawbacks including requiring a lengthy setup,being subject to measurement and marker placement errors, not providinga border that completely surrounds the test area, lacking any guidancefor how to sample the test area, and increasing the risk of exposure ofthe test operator to potential hazardous drug contamination throughplacement and removal of numerous adhesive markers.

The disclosed templates address this problem by providing an adhesiveborder defining an open area that, when the template is adhered to thetest surface, demarcates an area of a test surface for sampling. Theborder can be quickly and easily adhered to the test surface, providinga single adhesive marker that demarcates the entire border of aprecisely-defined test area of known dimensions, and then peeled awayonce sampling is completed. Such templates can be provided withalignment marks around the interior edge of the border to guide the userto perform optimal swabbing motions (which optimize, for example, thelikelihood that all trace contaminants, if present, will be collected onthe swab and that the total area that is actually swabbed is the same asor substantially the same as the test area of known dimensionsdemarcated by the border). The disclosed templates include a first innerportion and a second outer portion, wherein the first inner portion isseparated from the second outer portion prior to adhering the secondouter portion to the test surface. Separating the first inner portionfrom the second outer portion forms the border defining theprecisely-defined test area of known dimensions. Some embodiments canadditionally provide step-by-step graphical instructions for samplingprocedures in the first inner portion that a user separates from thesecond outer portion prior to adhering the second outer portion to thetest surface. Advantageously, the disclosed templates provide both areademarcation and visual guidance for alignment of swabbing motionswithout requiring a user to perform extra testing steps, therebyminimizing contact between the user and the sample.

FIGS. 2A-2C illustrate an example template 200 as described herein. FIG.2A illustrates the template prior to use. The template includes secondouter portion 210 (hereinafter “border 210”) and a removable first innerportion 220 (hereinafter “removable portion 220”) that is separable fromthe border 210 along separation line 205. In one non-limiting example,the template 200 is packaged in a sterile and heat-sealed polymer pouch,and provided to a user in a kit with other tools for the hazardous drugsampling and/or testing processes (e.g., a swab, a collection container,one or more assays, and a test device). The template can be packaged asshown in FIG. 2A as a solid square, with the removable portion 220 cut(fully or via spaced perforations) from border 210 along the separationline 205 but in contact with the border 210 due to both pieces beingremovably secured to a protective backing layer. In one non-limitingexample, the outer perimeter of the border 210 (and the template 200)measures about 15 inches by about 15 inches and the perimeter of theremovable portion 220 measures about 12 inches by about 12 inches.

The border 210 and removable portion 220 can be formed from a thinsubstrate, for example paper or a film or sheet of polymer. Thesubstrate can be flexible in some embodiments such that a user may bendthe substrate, for example during application of the border to a testsurface, without causing wrinkles or fractures in the border. In otherembodiments, the substrate can be a sheet of material with suitablerigidity for maintaining the shape of the open area demarcating the testarea. In some embodiments, the substrate used for the border 210 mayhave higher rigidity than the substrate used for the removable portion220 such that the border remains flat while the removable portion 220 isflexible. In some embodiments, the substrate can be pre-folded alongfold lines that enable the template to occupy a smaller area, forexample for shipping in a kit. The substrate can be planar in someembodiments. In other embodiments, the substrate can be formed in anon-planar (e.g., angled or contoured) shape that matches the profile ofa test surface so that the edges of the open area follow the shape ofthe test surface and lie flush against the test surface. The substratecan maintain its shape during swabbing of the test area, even if theswab contacts the substrate. In the illustrated embodiment, the outerportion of the border 210 is in the shape of a square frame and theremovable portion 220 is in the shape of a closed square. The border 210and the removable portion 220 can be formed in any suitable geometricshape, however. Further, the shape of the removable portion 220 need notmirror the shape of the border 210, for example in order to demarcate atest area of a particular desired shape. In one non-limiting example,the outer perimeter of the border 210 is in the shape of a circle andthe removable portion 220 is in the shape of a rectangle.

FIG. 2A illustrates the surface of the template that would face a userwith the template positioned on a test surface. As illustrated, thissurface is provided with a number of printed elements includinggraphical sampling instructions 225, wiping alignment markers 212, 214,and corner peel indicator 216. Though not illustrated, a barcode serialnumber, or other identification marker can be printed on the surface ofthe border 210 or removable portion 220 in order to identify thetemplate and the surface area of the open area 230 to a test device. Insome embodiments, for example embodiments of the template 200 that use apaper or other absorbent substrate, the portion of the surface facingthe user can be covered with a protective coating such as polypropylenelaminate in order to prevent buffer solution applied to the test surfaceduring sampling from being absorbed into the upper surface of thetemplate. Beneficially, in implementations designed to permanently orsemi-permanently adhere the template to the test surface, this can allowa user to clean the template 200 by wiping it down and protects theprinted ink. Even in implementations that remove the template from thetest surface after sample collection, the protective coating can preventbuffer solution from causing the ink to bleed.

The opposing surface (e.g., the surface that directly contacts the testsurface) can be provided with an adhesive (including but not limited toan adhesive layer) to adhere the template to a test surface. In variousembodiments, the adhesive may be configured for easy removal of thetemplate 200 from the test surface after sampling. For example, theadhesive may be a weak adhesive that allows a user to peel off thetemplate from the test surface after sampling with just two fingersgripping one corner. Alternatively, the adhesive may be a strongeradhesive to permanently or semi-permanently adhere the template to thetest surface. As an example, some embodiments may be provided with apressure-sensitive adhesive such as a silicone adhesive or a polymeremulsion adhesive (e.g., acrylic emulsion). The adhesive can beprotected by a removable protective layer prior to use, for example awaxy paper or plastic film.

The substrate can be scored or cut along the separation line 205, forexample as a continuous line or spaced-apart perforations, and suchscoring can extend through just the substrate or in some embodimentsalso through the protective backing layer. The corner peel indicator 216can be positioned over an area of the border 210 that is not providedwith adhesive to indicate to the user where the substrate of the border210 can easily be separated from the protective layer. Other embodimentsmay be manufactured from a material that utilizes static electricalforces to cling to the test surface, for example a thin plastic film,and in such embodiments the adhesive and protective layer can beomitted.

FIG. 2B shows the border 210 with the removable portion 220 removed tocreate an interior open area 230 for demarcating the test area. In someembodiments the four sides of the border 210 can have uniform thickness,for example spanning a thickness of at least 1.5 inches from the innerperimeter of the border 210 formed by the separation line 205 to theouter perimeter. In some embodiments the sides of the outer perimetercan be about 15 inches long, and the sides of the inner perimeter can beabout 12 inches long to demarcate a one foot square open area 230. Asillustrated, in some embodiments two of the sides of the border 210 canbe thicker (in this case, the left and bottom sides) than the other twosides (in this case, the right and top sides), however the minimumthickness may still be at least about 1.5 inches and the open area 230can still be a 12 inch by 12 inch square. The border thickness of atleast 1.5 inches can provide sufficient material for the user to controlthe border 210 during application to the test surface. Other sizes ofthe template border 210 can be used in other embodiments.

The inner perimeter of the border 210 formed by the separation line 205has four edges defining the open area 230. The open area 230 includesnegative space bounded by the inner perimeter of the border 210 anddefines a test area to be swabbed by the user. The size of the open areacan vary in different implementations of the template based on therequirements of the sampling procedure. Buffer solution can be appliedto the test area within the open area of the template, for example abuffer solution formulated to pick up the hazardous drug of interest.The buffer solution can be applied by wiping a pre-moistened swab to thetest surface in such a way that buffer solution is expressed onto thetest surface, and/or the buffer solution can be poured onto the testsurface from a container. In one non-limiting example, the buffersolution can flow along the test surface within the open area of thetemplate with its flow path bounded by the interior edges. Beneficially,this can contain the buffer solution within the test area andpotentially prevent hazardous contamination from spreading.

Some or all of the surface of the border 210 that is configured to beapplied against the test surface can be coated with adhesive forsecuring the border 210 to the test surface. Advantageously, thisadhesive can prevent buffer solution from moving outside the perimeterof the open area 230. Beneficially, adhering the border 210 to the testsurface can prevent the border 210 from moving during sampling, forexample in response to contact between the swab/handle and the border.If a user bumps an unsecured border 210 and moves it across the testsurface during sampling, then the actual area sampled is unknown eventhough the area of the open area 230 is known, because the open area 230has moved to a new location on the test surface during samplecollection. This can cause the user to sample from a larger area of thetest surface than the open area 230 as the template border 210 slidesover new areas. Maintaining a fixed location for the open area 230 canbe advantageous for determination of accurate test results, as itconstrains the actual area swabbed to the known area of the open area230. Fixing the border 210 to the test surface via an adhesive (orstatic cling) can beneficially keep the hands of the user away from thepotentially contaminated surface and any buffer liquid used during thesampling, as the user does not have to manually apply pressure to theborder 210 to keep it in place. The adhesive can have sufficiently hightack to keep the border 210 in place when contacted by the swab as it ismoved by the user during sampling. Some embodiments can also havesufficiently low tack to allow the user to easily peel the border 210off of the test surface when sampling is complete.

In this embodiment, the alignment markers 212, 214 extend from theseparation line 205 outward towards the outer edges of the template.Other configurations are suitable. Such alignment markers can visuallyassist a user to thoroughly and accurately sample the entire areademarcated by the open area 230. For example, a first set of thealignment markers 212 depicted with a first representation can indicateto the user to keep a center of the swab aligned with the marker and asecond set of the alignment markers 214 depicted with a second,different representation can indicate to the user to keep the edges ofthe swab aligned with the markers. In the illustrated embodiment, thefirst representation is a first line having a first length and thesecond representation is a second line having a second length less thanthe first length. In addition, in the illustrated embodiment, the firstrepresentation includes a first color (in this non-limiting example,orange) and the second representation includes a second, different color(in this non-limiting example, blue). The user can wipe the test surfacein a relatively straight line while maintaining the alignment of theswab and the markers, and then can move the swab into alignment with thenext adjacent set of markers, as discussed in more detail with respectto FIG. 3B below. In this manner, the template guides the user toperform swabbing in a controlled, constrained, and precise manner thatsamples the entirety of the test surface. Though depicted as lines, thealignment markers 212, 214 can include dots, bands of color or patterns,or other graphical representations suitable for visually indicating awiping path to the user. Some embodiments can include a single set ofalignment markers rather than different first and second sets 212, 214.

FIG. 2C shows the removable portion 220 after it has been removed fromthe border 210 along the separation line 205. As illustrated, theremovable portion 220 is provided with a graphical series of samplingsteps 225 similar to those discussed above with respect to FIG. 1A.Without such instructions, the area occupied by the removable portion220 would be blank and potentially of little or no use to the user. Thepresently-disclosed template design advantageously uses this material toprovide the user with sampling procedure instructions that areimmediately visible at the start of the sampling procedure and easilyaccessible by the user throughout the time of sampling with the template200.

Beneficially, some embodiments of the removable portion 220 can includean adhesive layer provided across some or all of the surface that makescontact with the test surface (opposing the illustrated surface),similar to the border 210. This can enable a user to secure thegraphical instructions near the test surface, for example on a wall,cabinet, pharmacy hood, or other structure adjacent to or near the testsurface. The instructions can be durable, for example coated with aprotective coating, and in some embodiments the adhesive can havesufficient tack to permanently or semi-permanently adhere the removableportion 220 to the structure near the test surface. In other embodimentsthe adhesive can have sufficiently low tack to allow the user to easilypeel the removable portion 220 away once sampling is complete.

FIG. 3A illustrates an example handle 300 secured to swab material 315that can be used to sample a test area demarcated by embodiments of thedisclosed templates. The handle 300 includes a grip portion 305 and abase portion 310 with the swab material 315 wrapped around and securedto the base portion 310, for example via ultrasonic welding, mechanicalfasteners, adhesive, or other suitable securing techniques.

As illustrated, the grip portion 305 extends perpendicularly from thecenter of one face of the base portion 310. The grip portion 305 canextend away from the base portion at other angles and/or from otherlocations along the width of the base portion 310 in other embodiments.The grip portion 305 can have a height sufficient to keep the fingers ofa user away from a surface in contact with the swab material secured tothe base portion 310, for example 0.25 inches or more, or 0.5 inches ormore, in various embodiments. In one non-limiting example, the height ofthe grip portion 305 is about 0.525 inches. The grip portion 305 canextend along the full width of the base portion 310 as illustrated, orcan extend along just a portion of the width of the base portion 310. Insome embodiments the length of the base portion can also assist inshielding the fingers of the user from the test surface, and the lengthcan be for example 0.25 inches or more, or 0.5 inches or more, invarious embodiments. In one non-limiting example, the length of the baseportion 310 is about 0.55 inches. Embodiments of the base portion 310with a length of about 0.55 inches can include about 0.2 inchesclearance on each side of the grip portion 305 for the user's fingers togrip the handle 300. This can shield the user's fingers from the testsurface below the base portion 310 during use of the handle 300, andcan, for example, act as a stop to prevent the user's fingers fromcontacting the test surface. Other sizes can be suitable for otherembodiments, and the disclosed dimensions are provided to illustrate andnot limit the dimensions of the handle 300.

The swab material 315 is configured to be loose enough to form a gap 325between the swab material 315 and the adjacent surface of the baseportion 310. The gap 325 can enable the swab material 315 to be agitatedby buffer solution when shaken within a collection vial in order toextract collected contaminants from the swab material 315. The gap 325can be between 0.25 inches and 0.75 inches in some embodiments. The swabmaterial 315 may be longer than the base 310 of the handle 300 such thataround 0.25 inches of swab material 315 extends beyond the edges of thebase 310. The base 310 can have a width of around 2 inches in someembodiments.

FIG. 3B illustrates an example swabbing pattern 330 using the handle 300of FIG. 3A within the border 210 of the template of FIG. 2B. As shown,the user can align the center of the width of the handle 300 with one ofthe first set of alignment markers 212. Two adjacent markers 214 of thesecond set of alignment markers align with the opposing edges of thewidth of the base of the handle 300. In this non-limiting embodiment,the swab material extends a small distance beyond these edges of thebase of the handle 300. In one example, adjacent markers are positioned1 inch apart, with the first and last markers 212 are each positioned 1inch from the adjacent interior edge of the border 210. This correspondsto an open area of 12 inches by 12 inches, and in such embodiments thebase of the handle 300 can have a width of 2 inches. In suchembodiments, with six precise, linear strokes (as shown by the swabbingpattern 330), the user can sample the entire test surface exposedthrough the border 210 with precision and minimal deviation from theoptimal swab pattern.

The user can begin swabbing with the center of the handle 300 alignedwith a first alignment marker 212. The user can move the handle 300 in astraight line between the first alignment maker 212 on a first interioredge of the border 210 and a corresponding alignment marker on theopposing interior edge of the border 210. The handle 300 can be incontact with a third interior edge of the border 210 (in the illustratedembodiment, the leftmost interior edge) during this first swab stroke.Once the user has swabbed from the first interior edge of the border 210to the opposing interior edge, the user can move the center of thehandle 300 into alignment with a next alignment marker 212 and cancontinue moving the swab in a linear fashion along a second line betweenthat alignment marker and the corresponding alignment marker on thefirst edge. The swab material extending beyond the edges of the basecauses a slight overlap between the areas swabbed when the handle 300 ismoved along the first line and the second line, and similarly causesoverlap between adjacent lines as the handle 300 is moved according tothe pattern 330. This overlap beneficially assists the user in swabbingthe entire area of the test surface bounded by the border 210. Forexample, the overlap allows the user to deviate slightly from theintended alignment and still swab the entire test surface.

The swabbing pattern 330 described with reference to FIG. 3B is just oneexample of a suitable swabbing pattern using implementations oftemplates described herein. Another example swabbing pattern 330 isshown in FIG. 3C, which illustrates swab strokes in a horizontalorientation rather than a vertical orientation.

FIG. 4 illustrates example steps 400 of two different techniques forapplication of the template of FIGS. 2A-2C to a test surface. This canoccur before or at step 102 of the process 100A described with referenceto FIG. 1A above. Some embodiments of these techniques can be performedmanually by a user, for example after the user puts on protective glovesat step 101 of the process 100A. Some embodiments can be performed usingtools such as a roller that can help keep the user's hands away from thepotentially contaminated test surface. For example, each individualtemplate may be provided on a disposable roll. In another example, areusable rolling tool can be provided with a number of templates. Thetemplates can be connected end-to-end (e.g., via separation lines) alonga rolled substrate, with the rolled substrate secured onto the reusablerolling tool such that multiple templates can be rolled onto desiredsurfaces from the reusable rolling tool. FIGS. 5A and 5B depictphotographs of the template of FIGS. 2A-2C at different stages of theapplication process of FIG. 4, and so are discussed together withcertain steps of FIG. 4 below.

Both techniques can begin at step 405, at which the user obtains thetemplate, for example by removing the template from sterile packaging.Providing the disclosed templates in sterile packaging, such as heatsealed foil or polymer pouches, can assist in accurate measurements oftest results by mitigating introduction of contaminants into the sampleby the template. As described above, the template can be provided in twoparts—a border and a removable central portion—both secured to aprotective backing layer via adhesive.

For the first application technique (labeled a “corner rollout method”),the user moves to step 410 and peels off a corner of the template borderfrom the protective backing. The corner peel indicator 216 describedabove can be positioned over this area of the border to guide the userin performing step 410. At step 410, the user can place the exposedadhesive at or around the corner onto the test surface to begin securingthe template border to the surface. In some embodiments, the user mayremove the removable portion 220 from the border prior to step 410,however in some embodiments the substrate of the removable portion canbe flexible and it is not required to be removed. The user can bend theflexible protective backing, together with the removable portion if itremains secured to the protective backing, underneath the border (e.g.,between the unsecured portion of the border and the test surface) andaway from the secured corner of the border.

At step 415, the user can continue to roll the protective backing awayfrom the secured corner as depicted by the arrow, thereby progressivelypeeling the protective backing off of the border. As additional portionsof the adhesive of the border are exposed by this peeling, the user canpress such portions onto the test surface, being careful to keep theinterior edges of the border flat and straight to maintain the open areaof the border at its expected size (e.g., by not wrinkling the borderthus creating a smaller open area than expected for the template).

FIG. 5A depicts a photograph of an example of step 415 in which theremovable portion 220 is still affixed to the protective backing layer.As shown in FIG. 5A, the user has bent the removable portion 220 underthe unsecured portion of the border 210 and away from the secured corner(under graphic 216). The user pulls the backing layer and the removableportion 220 toward the corner that diagonally opposes the securedcorner, thus peeling the backing from portions of the border 210. Thispeeling motion also separates the removable portion 220 from the border210 along separation line 205, with separation line 205 now forming theinterior edges of the border 210 that will demarcate the test area. Theexposed adhesive is used to seal the border 210 to the test surface,with the user exercising care to keep the interior edges straight and toseal the corners such that the adjacent interior edges at the corner arepositioned at 90 degrees to one another.

Once the backing has been completely removed from the border 210, theuser adheres the final corner of the border 210 to the test surface, andthe border 210 is fully adhered to the test surface as shown at step420. The user can now proceed through the remaining sampling steps, forexample moving to step 103 of the process 100A.

For the second application technique (labeled a “peel and placemethod”), the user moves from step 405 to step 425 to peel the templateborder away from the protective backing layer. FIG. 5B depicts aphotograph of an example of step 425 in which the user is peeling theborder 210 away from the protective backing layer 500. In this example,the removable portion 220 with the graphical use instructions is stillsecured to the backing layer 500. The user peeling the border 210 awayfrom the protective backing layer 500 causes the border 210 to separatefrom the removable portion 220 along separation line 205, withseparation line 205 now forming the interior edges of the border 210that will demarcate the test area. In other embodiments the user mayfirst remove the removable portion 220 from the interior of the border210 before peeling the border 210 away from protective backing layer500.

Once the border 210 has been completely removed from the protectivebacking layer 500, the user moves to step 430 to secure one edge of theborder (in this example, the bottom edge) to the test surface. The usercontinues “rolling” the template onto the surface along two opposingedges that extend from the edge initially secured to the surface,gradually securing these edges to the surface and taking care to securethem parallel to one another and in straight lines. Once these two edgesare secured to the test surface, the user finishes step 430 by securingthe last edge to the test surface (in this example, the top edge), andthe border 210 is fully adhered to the test surface as shown at step420. The user can now proceed through the remaining sampling steps, forexample moving to step 103 of the process 100A.

Implementing Systems and Terminology

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isrequired for proper operation of the method that is being described, theorder and/or use of specific steps and/or actions may be modifiedwithout departing from the scope of the claims.

The term “determining” encompasses a wide variety of actions and,therefore, “determining” can include calculating, computing, processing,deriving, investigating, looking up (e.g., looking up in a table, adatabase or another data structure), ascertaining and the like. Also,“determining” can include receiving (e.g., receiving information),accessing (e.g., accessing data in a memory) and the like. Also,“determining” can include resolving, selecting, choosing, establishingand the like. The phrase “based on” can mean “based only on” and “basedat least on,” unless expressly specified otherwise.

The previous description of the disclosed implementations is provided toenable any person skilled in the art to make or use the presentdisclosure. Various modifications to these implementations will bereadily apparent to those skilled in the art, and the generic principlesdefined herein may be applied to other implementations without departingfrom the scope of the invention. Thus, the present invention is notintended to be limited to the implementations shown herein but is to beaccorded the widest scope consistent with the principles and novelfeatures disclosed herein.

What is claimed is:
 1. A system for guiding collection of a hazardous contaminant sample, comprising: a handle configured for collection of the hazardous contaminant sample from a test surface; and a template including a border having an outer perimeter and an inner perimeter with edges of the inner perimeter defining an open area configured to demarcate a test area for the collection of the hazardous contaminant sample, and a plurality of alignment markings provided along at least one of the edges of the inner perimeter, the plurality of alignment markings provided at a spacing selected to provide visual guidance to a user for wiping the entire test area with the handle.
 2. The system of claim 1, wherein the border is formed from a substrate, wherein the plurality of alignment markings are printed on a first surface of the substrate, the template further comprising an adhesive provided on a second surface of the substrate opposing the first surface.
 3. The system of claim 2, further comprising a protective backing layer removably provided to cover the adhesive prior to use.
 4. The system of claim 3, further comprising a removable portion of the template secured to the protective backing layer within the open area of the border.
 5. The system of claim 4, wherein the substrate comprises the removable portion, the removable portion further comprising at least one graphical instruction for guiding the user through the collection of the hazardous contaminant sample printed on the first surface.
 6. The system of claim 4, wherein the substrate comprises the removable portion, the system further comprising a separation line extending through the substrate and separating the border and the removable portion.
 7. The system of claim 1, further comprising a reader device configured to determine a test result based on the hazardous contaminant sample collected from the test surface within the test area demarcated by the template.
 8. The system of claim 7, wherein the border comprises a machine-readable pattern identifying the surface area of the test area, wherein the reader device includes: a scanning device, at least one computer-readable memory having stored thereon executable instructions, and one or more processors in communication with the at least one computer-readable memory and configured to execute the instructions to cause the reader device to cause the scanning device to capture data representing the machine-readable pattern, and determine the surface area of the test area based on analyzing the data.
 9. A system for guiding collection of a hazardous contaminant sample, comprising: a template including a border having an outer perimeter and an inner perimeter with edges of the inner perimeter defining an open area configured to demarcate a test area for the collection of the hazardous contaminant sample; and a reader device configured to receive an indication of a surface area of the test area of the template, and to determine a test result based on the hazardous contaminant sample from the test surface and on the surface area of the test area of the template.
 10. The system of claim 9, wherein the border comprises a plurality of alignment markings provided along at least one of the edges of the inner perimeter, the plurality of alignment markings provided at a spacing selected to provide visual guidance to a user for wiping the entire test area.
 11. The system of claim 10, wherein the border is formed from a substrate, and wherein the plurality of alignment markings are printed on a first surface of the substrate, the template further comprising an adhesive provided on a second surface of the substrate opposing the first surface.
 12. The system of claim 11, further comprising a protective backing layer removably provided to cover the adhesive prior to use.
 13. The system of claim 12, further comprising a removable portion of the template secured to the protective backing layer within the open area of the border.
 14. The system of claim 13, wherein the substrate comprises the removable portion, the removable portion further comprising at least one graphical instruction for guiding the user through the collection of the hazardous contaminant sample printed on the first surface.
 15. The system of claim 13, wherein the substrate comprises the removable portion, the system further comprising a separation line extending through the substrate and separating the border and the removable portion.
 16. The system of claim 9, wherein one surface of the template is provided with an adhesive, the template further comprising a protective backing layer removably provided to cover the adhesive prior to use.
 17. A template for guiding collection of a hazardous contaminant sample from a surface, comprising: a substrate comprising: a border having an outer perimeter and an inner perimeter with edges of the inner perimeter defining an open area configured to demarcate a test area on the surface for the collection of the hazardous contaminant sample, a separation line provided as one or more cuts through the substrate along the inner perimeter, and a removable portion provided within the inner perimeter; an adhesive provided on a surface of the substrate configured to secure at least the border to the surface; and a protective backing layer removably provided to cover the adhesive prior to use.
 18. The template of claim 17, wherein the adhesive secures the border and the removable portion to the protective backing layer prior to use.
 19. The template of claim 17, wherein the border comprises a plurality of alignment markings provided at a spacing selected to provide visual guidance to a user for wiping the entire test area.
 20. The template of claim 17, wherein the removable portion comprises at least one graphical instruction for guiding a user through the collection of the hazardous contaminant sample.
 21. The template of claim 17, wherein the removable portion is configured to be removed from the border prior to the collection of the hazardous contaminant sample.
 22. A method for applying a template for guiding collection of a hazardous contaminant sample to a surface, comprising: obtaining the template of claim 17; peeling the border away from the protective backing layer at a first corner of the border; securing the first corner of the border to the surface using an exposed portion of the adhesive; folding the protective backing layer away from the first corner and under a portion of the border that is unsecured to the surface; peeling the protective backing layer away from the first corner to progressively expose more of the adhesive; securing additional portions of the border to the surface using corresponding portions of the adhesive as it is progressively exposed; and upon fully removing the protective backing layer from the border, securing a second corner of the border to the surface, the second corner diagonally opposing the first corner.
 23. A method for applying a template for guiding collection of a hazardous contaminant sample to a surface, comprising: obtaining the template of claim 17; completely removing the border from the protective backing layer; securing a first edge of the border to the surface using a portion of the adhesive provided on the first edge; progressively securing portions of second and third edges of the border onto the surface using corresponding portions of the adhesive provided on the portions of the second and third edges, the second and third edges extending from the first edge; and securing a fourth edge of the border to the surface using a portion of the adhesive provided on the fourth edge, the fourth edge opposing the first edge and connecting the second and third edges. 